Humalog: adverse event reports filed with FDA

71,174

reports as suspect product

0.3% of all reports · about 3,164 a year

2,312

reports, 12 months to June 2026

4,054 in the 12 months before

34.4%

marked serious by the reporter

42.7% across the class

1.8%

record death among outcomes, as reported

1,312 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Humalog reports recording the termmedian drug in insulin analog

1. Blood glucose increasedraised blood sugar reading40.6%28,930
2. Incorrect dose administeredthe wrong dose was given9.4%6,719
3. Blood glucose decreasedlow blood sugar reading9%6,374
4. Drug ineffectivethe medicine did not work as expected7.2%5,120
5. Visual impairmentreduced vision5.3%3,788
6. Underdoseless than the intended dose3.8%2,719
7. Drug dose omissiona dose was missed3.8%2,706
8. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure3.1%2,217
9. Malaisegeneral feeling of being unwell3%2,136
10. Hypoglycaemialow blood sugar2.9%2,092
11. Blood glucose abnormal2.8%2,025
12. Cataractclouding of the eye lens2.3%1,618
13. Injection site painpain where the injection was given2.3%1,617
14. Haemorrhagebleeding2.2%1,549
15. Falla fall2.1%1,507
16. Visual acuity reducedreduced sharpness of vision1.9%1,382
17. Wrong technique in product usage processthe product was used in the wrong way1.9%1,327
18. Cerebrovascular accidentstroke1.8%1,307
19. Accidental underdose1.8%1,282
20. Feeling abnormalfeeling odd or not right1.7%1,223
21. Memory impairmentmemory problems1.7%1,184
22. Blood glucose fluctuation1.6%1,152
23. Weight decreasedweight loss1.6%1,139
24. Drug dispensing errora dispensing mistake1.6%1,126
25. Wrong drug administeredthe wrong medicine was given1.5%1,083
26. Dizzinesslight-headedness or unsteadiness1.5%1,078
27. Painpain, site not specified1.5%1,046
28. Weight increasedweight gain1.5%1,034
29. Diabetic ketoacidosisa serious complication of diabetes with acid build-up1.4%1,018
30. Nauseafeeling sick1.4%1,009

Top 30 of 2,046 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 26 drugs in the insulin analog class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 289,293 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 89.8% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 71,174 reports.

Drugs most often listed in the same reports

Other products listed in reports where Humalog is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the insulin analog class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Humalog as a suspect or interacting product; reports listing it only as a concomitant medication (40,195) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.